BEUDAMED
    Product Code: NME FDA class 1 21 CFR 872.3240

    Bur, Diamond Coated, Reprocessed

    Dental

    The Reprocessed Diamond-Coated Dental Bur is a reprocessed dental rotary cutting instrument with a diamond coating used for cutting, grinding, and shaping tooth structure and dental materials; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 1 (General Controls), under product code NME and regulation 21 CFR 872.3240 in the Dental specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.

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    510(k)s
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    FEI Numbers
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    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    NME
    Device Class
    FDA class 1
    Regulation Number
    872.3240
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
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    Summary Malfunction Reporting

    Definition

    Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).